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The CE interviews were conducted with four nephrologists and among adults (aged\u2009\u2265\u200918 years) and adolescents (aged 12\u201317 years) diagnosed with NS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In total, 45 adult and adolescent patients were interviewed across all CE and CD interviews. In the adult CE interviews, the most frequently reported symptoms were swelling in the feet\/legs (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200914\/16), general tiredness (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200913\/16), change in appetite (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200913\/16), foamy urine (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200912\/16), and shortness of breath (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200912\/16); impacts included emotional health, physical function limitations, sleep difficulties, and social\/lifestyle limitations (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200913\/16). In adolescents, the most frequently reported symptoms were tiredness\/fatigue (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200913\/15), stomachache (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200911\/15), headache (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20098\/15), foamy\/frothy urine (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20097\/15), swelling in face\/eyes (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20096\/15), swelling in legs\/ankles (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20095\/15), and change in appetite (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20095\/15), while the most common impacts were impact on schooling (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200910\/15), reduced ability to practice sports (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20097\/15), and impact on friendship (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20097\/15). A conceptual model was developed and used to inform item generation for the NephroSSI-PRO. During CD interviews, there were no challenges in understanding and relating to instrument instructions, items, and response options.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>We have developed a PRO instrument to evaluate the symptoms and impacts of NS in adult and adolescent patients. In this study, the evidence from a literature review, and direct patient input from CE and CD support its content validity. Further work supporting the instrument\u2019s validity will be performed in a future clinical trial.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s41687-025-00937-7","type":"journal-article","created":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T09:16:46Z","timestamp":1755767806000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Development of the Nephrotic Syndrome Symptom and Impact Patient Reported Outcome (NephroSSI-PRO) measure for use in adults and adolescents with primary glomerulopathies"],"prefix":"10.1186","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1889-8931","authenticated-orcid":false,"given":"Joshua","family":"Maher","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"An-Qi","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sagar U.","family":"Nigwekar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Lin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,8,21]]},"reference":[{"key":"937_CR1","unstructured":"US FDA (2009) Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. https:\/\/www.fda.gov\/media\/77832\/download. 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The adult study protocol was approved by Quorum Review (an independent ethics review board, now Advarra (please note, the Quorum Review archive is no longer available), and the adolescent study protocol was approved by the WCG IRB (study number 20233718). Informed consent was obtained from all participants and parents\/caregivers of adolescent patients included in this research and they were remunerated for their time according to the Fair Market Value rates.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All authors consent to publish the manuscript.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"JH and AH are employees of Sanofi and hold stocks and\/or stock options in the company. JL was an employee of Sanofi when the manuscript was drafted. SUN is a Mass General Brigham Innovation Fellow with part-time fellowship supported by Sanofi.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"106"}}